Senior CQV Engineer: Process Validation Lead

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Sr CQV Engineer 1 to lead commissioning and qualification activities for process support equipment and systems. The role drives CQV strategy, SOPs, and qualification plans, and mentors junior engineers to ensure CQV integration into site projects.

You will collaborate with Manufacturing, Process Science, Automation, Quality, and Supply Chain to ensure GMP and regulatory standards are met and aligned with global practices across the

Qualifications

• Bachelor's degree in Engineering is required.
• 8 years of experience in validation activities in facilities, commissioning, and systems qualifications.
• Experience with cGMP or working in another highly regulated industry.

Responsibilities

• Lead CQV validation strategies for process support equipment that align with GMP principles.
• Manage validation lifecycle from IV to PQ and GMP release.
• Provide technical support and guide external validation engineers.
• Collaborate with cross-network to align validation programs with global standards.
• Liaise with Manufacturing, Process Science, Automation, Quality, and Supply Chain to meet validation requirements.
• Establish SOPs, Validation Project Plan, and Validation Master Plan for cGMP compliance.
• Lead deviation investigations and RCA with CAPA remediation.
• Provide training to junior engineers.

Skills

CQV leadership

Cross-functional collaboration

Training junior engineers

Problem solving

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Sr CQV Engineer 1 to lead commissioning and qualification activities for process support equipment and systems. The role drives CQV strategy, SOPs, and qualification plans, and mentors junior engineers to ensure CQV integration into site projects.

You will collaborate with Manufacturing, Process Science, Automation, Quality, and Supply Chain to ensure GMP and regulatory standards are met and aligned with global practices across the